This invention relates generally to medicament container/dispensers such as intravenous bags, bottles or the like, and more particularly, is directed to such devices as are prepared and used for the intravenous delivery of medicaments in premeasured dosages.
It is estimated that over 675 million intravenous (IV) containers are sold, and that about 240 million intravenous (IV) unit doses of various medicaments or drugs are given annually in the United States. In the past, most of these doses have been prepared under sterile conditions in hospital pharmacies. Recently, however, a number of pharmaceutical manufacturers have been producing and selling some of the more popular drugs in small pre-mixed IV bags, typically in sizes of 50 cc and 100 cc. Because of the overall labor savings, economy and ease of use, these products have gained in popularity, and sales thereof have increased dramatically.
However, although the IV bags are generally suitable for drugs which are stable at room temperature when premixed, unstable drugs cannot be contained in pre-mixed form in such IV bags. To overcome this problem, some of these products are being packaged and sold in frozen form, or alternatively, in a double-bag configuration in which the contents of one IV bag can be released into the contents of the other IV bag to mix the components at a subsequent time. As will be appreciated, such double-bag configuration is relatively expensive and cumbersome to manufacture and use. In an alternate system, the IV bag is provided with a vial port for receiving a drug-containing vial which is screwed thereinto. This IV bag with a separately packaged drug vial is also relatively expensive and cumbersome to use.
In an attempt to cure the above problems, various devices have been provided. Specifically, various containers have been provided in which an unstable drug is separated from a stable drug by a rupturable membrane. In such case, a piercing or cutting element is provided for rupturing the membrane in order to mix the unstable drug with the liquid medicament.
For example, U.S. Pat. No. 2,721,552 to Nosik discloses a multiple chamber container in which, as shown in FIG. 5 thereof, a tubular shaped receptacle has an opening at the upper end thereof and a sterile liquid, such as water, is held within the receptacle. The upper end of the receptacle is sealed by a rupturable membrane. A second chamber is formed in an elastic deformable closure member that has a dependent flange in overlapping engagement with the upper end of the receptacle, so as to secure the closure member with the receptacle. A bore is provided in the closure member and has a tubular piercing member slidably retained therein. The lower end of the bore is sealed by a rupturable membrane. A solid medicament is positioned within the bore for mixing with the liquid in the receptacle. Specifically, the closure member is deformable so as to move the tubular piercing member downwardly so as to rupture the membrane closing the lower end of the bore of the closure member and the membrane closing the upper end of the receptacle. As a result, the solid medicament within the bore falls into and mixes with the liquid. The mixed material can then be removed with a hypodermic needle. In addition, the piercing member may be sealed to the closure member to prevent the escape thereof within the receptacle.
However, such arrangement has various disadvantages. In the first place, there is the possibility that accidental pressure on the closure member, during shipping or storage, will result in the piercing member rupturing the membranes, thus rendering the container, or at least the closure member portion thereof if separated from the container, unusable. As a result, shipping and storage of such container is relatively difficult and expensive. Further, because of the specific arrangement in which the piston is slidably positioned within the bore of the closure member, construction of the closure member becomes relatively complicated and expensive. Also, when compressing the closure member to rupture the membranes, there is an undesirable increase in pressure, or a back-pressure, provided in the receptacle. Accordingly, Nosik cannot be used as an IV container/dispenser, since without any means of pressure equalization, not only will there be a pressure build-up when the closure is ruptured, but also, as the liquid flows from the container, a vacuum will form which will slow and then stop the evacuation of the container.
In addition, in Nosik, the puncturing element is a tube which falls into the solution or is attached to the top of the container. Clearly, it is not desirable to have a free floating element in an IV container. On the other hand, if the puncturing or piercing tube is attached, when the sealing cap is depressed so as to force the piercing tube into its cutting relation, the piercing tube will block the opening which it has created unless the sealing cap springs back to its initial position, which cannot be assured. See also U.S. Pat. Nos. 2,275,567 to Smith; 3,840,136 to Lanfranconi et al; 3,968,872 to Cavazza; U.S. Pat. No. 4,187,893 to Bujan; 4,417,890 to Dennehey et al; 4,515,586; U.S. Pat. No. 4,601,704 to Larkin; and U.S. Pat. No. 4,693,711 to Bremer et al for similar disclosures. Also of interest in this regard are U.S. Pat. Nos. 3,306,563; 3,915,212; 4,161,178; 4,294,351; 4,392,850; 4,467,588; 4,548,606; 4,602,910; 4,608,043.
In addition, similar devices are known for use with syringes. For example, U.S. Pat. No. 4,693,706 to Ennis discloses a two compartment mixing syringe having an inner cylindrical barrel which is open at one end and closed at its opposite end by a thin membrane bonded thereto. The inner cylindrical barrel contains a diluent. A plunger is slidably inserted in the inner cylindrical barrel and has a sliding, sealing head which applies pressure to the diluent therein to rupture the membrane when the plunger is advanced. The inner barrel is slidably inserted in an open end of an outer barrel in sealing relationship therewith. The outer barrel contains a liquid or solid drug for mixing with the diluent in the inner cylindrical barrel when the membrane is ruptured. The mixture is discharged from the outer barrel via the tip thereof when the plunger is advanced axially in the inner barrel.
However, with this device, sealing of the diluent in the inner cylindrical barrel occurs by reason of the thin membrane bonded at the lower end thereof and the plunger at the opposite end thereof. Although the thin membrane is sufficient to provide an adequate seal for the diluent, the plunger may not be sufficient to provide an adequate seal for long-term storage. As a result, the diluent within the inner cylindrical barrel may deteriorate over time. Also, by its very nature, the two-barrel syringe requires close mechanical tolerances in order to function properly without any back-flow of the ingredients and with smooth mechanical operation. Thus, this device will be relatively expensive to manufacture. Still further, this device also poses the same problem as that discussed above with respect to the container of Nosik in that accidental pressure on the plunger may rupture the thin membrane secured to the lower end of the inner cylindrical barrel. Thus, shipping and storage of the mixing syringe of Ennis becomes difficult and expensive. Also, the problem of back pressure when starting to depress the plunger is a concern. In addition, since the membrane is ruptured by hydrostatic pressure of the liquid driven by the advancing plunger, there is no mechanical cutting head for fracturing the membrane in a precise manner, and the actual manner and time of rupture is never fully defined, and will vary from unit to unit.
Still further, because the drug in the outer cylindrical barrel is sealed by the inner cylindrical barrel extending therein, and the diluent in the inner cylindrical barrel is sealed by the plunger, the entire assembly of the inner cylindrical barrel, outer cylindrical barrel and plunger must be shipped in assembled form, thus increasing the cost. In addition, because the mixing syringe must be shipped and stored in assembled form, the number of different types of mixing syringes, that is, the number of different combinations of drugs in the outer cylindrical barrel and diluent in the inner cylindrical barrel is increased. A simple example of this increase in the number of combinations will suffice. Assume that there are three different types of drugs A, B, or C that can be held within the outer cylindrical barrel and three different types of diluent X, Y, or Z that can be held in the inner cylindrical barrel, there are nine possible combinations, namely, AX, AY, AZ, BX, BY, BZ, CX, CY, and CZ. However, there are only six different and separate elements, namely, A, B, C, X, Y, and Z. Therefore, if the inner cylindrical barrel and outer cylindrical barrel can be shipped and stored separately, there are only six types of containers that need be produced, that is, three inner cylindrical barrels and three outer cylindrical barrels, rather than the nine possible combinations. As the number of possibilities of drug mixing increases, the number of combinations also increases relative to the number of individual drugs that are used, thereby adding to the complexity of production and storage. For similar disclosures, see also U.S. Pat. Nos. 2,590,900 to Sommerstein; 3,255,752; 3,340,873 to Solowey; 3,380,451 to Porter et al; 3,685,514 to Cheney; 3,718,139 to Hanford; 3,838,689 to Cohn; 4,171,698 to Genese; 4,331,146 to Brignola; 4,405,317 to Case; 4,464,174 to Ennis; and 4,516,967 to Kopfer. Other devices which are less relevant by are related to the above are also found in U.S. Pat. Nos. 2,778,360; 3,447,432; 3,557,787; 3,636,950; 3,875,012; 4,048,999; 4,059,112; 4,089,432; 4,172,457; 4,289,648; 4,306,554; and 4,412,836.
Other patents which were uncovered or cited in the parent of the present Application are also noted for completeness as U.S. Pat. Nos. 2,854,977; 3,059,643; 3,128,917; 3,I57,481; 3,193,993; 3,206,080; 3,881,640; 4,029,094; 4,356,012; 4,415,393; 4,432,760; 4,475,914; 4,583,971; 4,606,734; 4,614,515; 4,675,017; and 4,675,019.
Further, when IV solutions are administered to a patient, the IV container must be hung from a pole. It is highly desirable that the container hangs straight down so the medical personnel can easily determine the amount of solution that has been administered and the amount that remains in the container, by reading the graduations printed on the container. However, the hanger used with IV bottles and bags makes it difficult to hang the container in a perfectly straight position. Accordingly, incorrect readings may result, to the detriment of the patient. Further, with IV bags, when the bags are hung, the graduations may deform somewhat under the pull of gravity making the reading less than completely accurate.